Ovarian Stimulation With FSH Alone Versus FSH Plus a GnRH Antagonist in an Oocyte Donor/Recipient Programme: a Protocol for a Non-randomised Multicenter Study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Rate of concentration of progesterone >1 ng/ml
研究概览
简要总结
The aim of this study is to compare the efficacy of a protocol using FSH alone with that of a protocol using FSH plus a GnRH antagonist for controlled ovarian hyperstimulation in cycles of elective freezing in the context of a donor/recipient programme.
详细描述
The hypothesis to be tested is that an ovarian stimulation protocol that includes FSH alone without any LH surge prevention regimens is not inferior to a protocol including FSH plus a GnRH antagonist in terms of clinical outcome in a donor/recipient model.
The formal sample size is calculated as follows:
If there is a true difference in favour of the experimental treatment of 5% (20% vs 15%), then 160 patients (80 per group in case of 1:1 enrolment) are required to be 80% sure that the upper limit of a one-sided 95% confidence interval (or equivalently a 90% two-sided confidence interval) will exclude a difference in favour of the standard/control group of more than 10%.
In the context of the present pilot study (as a first stage), the investigators intend to study 50 patients (25 per group in case of 1:1 enrolment). At a second stage the above mentioned sample size will be used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 32 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •healthy women 21-32 years old with a BMI of 21 to 29 kg/m2 who wish to donate their oocytes
- •normal ovarian reserve tests
- •normal menstrual cycles of 26-32 days
- •the women would not have received any hormonal treatment during the last three months before entering the study.
- •absence of coagulation and/or autoimmune disorders.
排除标准
- •Use of other protocols towards oocyte retrieval, such as natural, or modified natural cycles
- •Poor ovarian response according to the Bologna criteria [22],
- •History of endocrine or metabolic disorders, ovarian cystectomy or oophorectomy,
- •Women with the diagnosis of polycystic ovary syndrome
- •Clinical and/or laboratory markers of hereditary or acquired thrombophilia that complied to the standard protocols of each Unit.
- •Non-hormonal medication for a serious medical condition
研究组 & 干预措施
FSH + GnRH antagonist
Women receive 225-300 IU s.c. FSH, and a GnRH antagonist from day 6 of FSH treatment at the dose of 0.25 mg per day until the triggering day. The GnRH antagonist in group 2 is injected each time immediately after the injection of FSH.
干预措施: GnRH antagonist (Other)
FSH only (no GnRH antagonist)
Women receive only FSH starting on day 2 of the cycle. The starting dose of FSH is 225-300 IU s.c. for the first 4 days adjusted thereafter according to the ovarian response.
干预措施: GnRH antagonist (Other)
结局指标
主要结局
Rate of concentration of progesterone >1 ng/ml
时间窗: At any time within 3 weeks after start of ovarian stimulation.
Concentration of progesterone elevation \>1 ng/ml
Rate of LH secretory peaks
时间窗: 3 weeks after start of ovarian stimulation.
A secretory peak of LH is defined as the increase at levels ≥10 IU/l.
次要结局
- Rate of ongoing clinical pregnancy(12 weeks after last menstrual period)
- Rate of miscarriage(Within 20 weeks after last menstrual period)
研究者
Siristatidis Charalampos, MD, PhD
Professor in Obstetrics - Gynecology & Reproductive Medicine
National and Kapodistrian University of Athens